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OpenTrials
Completed

NCT Number: NCT04290195

Use of Ziv Aflibercept in Different Retinal Diseases

A prospective interventional case series study was conducted on 20 eyes of 20 patients with active myopic choroidal neovascularisation (CNV) ,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic central retinal vein occlusion(CRVO) after approval of the Ethical Committee of the Faculty of Medicine, Tanta University . All procedures were carried out under the tenets of the Helsinki Declaration. Written consent was provided by all participants after discussing the procedure, alternative treatment plans, follow-up schedules, and possible benefits and risks.

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Key information

Conditions

Central Retinal Vein Occlusion With Macular Edema

Age range

31 year–63 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tanta University

Tanta, El Gharbia, 31111, Egypt

About this study

Intravitreal injection of 1.25 mg of ziv aflibercept was done in different retinal diseases including myopic CVN,resistant diabetic macular edema to previous ranibizumab injection and non ischaemic CRVO .Thorough ophthalmic evaluation was done including BCVA(best corrected visual acuity) ,anterior and posterior segment examination ,fundus fluorescein angiography and OCT(optical coherence tomography) were performed for all patients .Injection was repeated as PRN(pro re nata) method after one month if persistent intraretinal or subretinal fluid was found.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The study included treatment naive patients suffering from recently diagnosed active myopic subfoveal or juxtafoveal CNV less than 2 months documented by fundus fluorescein angiography (FFA)and optical coherence tomography (OCT ) , pathological myopia more than 6 D was included .

Exclusion criteria

  • Previous intraocular surgery .
  • Coincident retinal pathology as diabetic retinopathy, retinal vein occlusion .
  • CNV due to other causes like age related macular degeneration ,angioid streaks,trauma and choroiditis.
  • Extrafoveal myopic CNV .
  • Patients received other lines of treatment for CNV like photodynamic therapy ,laser photocoagulation or intravitreal injection of triamcinolone or other anti VEGF(vascular endothelial growth factor) agents.
  • Known glaucoma , clinical suspicion of glaucoma or IOP(intraocular pressure) more than 20 mmHg.
  • Prior ocular inflammation.
  • The presence of retinal degeneration.
  • Patients who didnot complete 6 months of follow up

Treatment and study plan

Ziv-Aflibercept 25 MG/ML [Zaltrap]

Drug

Intravitreal injection of 1.25 mg of ziv aflibercept in patients

Other names: zaltrap

Primary outcomes

  1. Improvement of BCVA by log MAR(minimum angle of resolution) and reduction of CMT after intravitreal injection

    Time frame: 6 months

    To assess sustained improvement of BCVA(Best corrected visual acuity) and reduction of the CMT (central macular thickness) after intravitreal injection of zivaflibercept

Sponsors and collaborators

Lead sponsor

Amin El Sayed Nawar

Other

Collaborators

  • Tanta University

Registry information

Official study title

Safety and Efficacy of Ziv Aflibercept in Myopic Choroidal Neovascularisation ,Central Retinal Vein Occlusion and Resistant Diabetic Macular Edema

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 28, 2020
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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